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Product Code:10529

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Description

PREDNISTAB

(Prednisolone)

PrednisTab (Prednisolone) is a potent anti-inflammatory steroid for use in dogs only. Prednistab is used in the treatment of various conditions known to respond
to the anti-inflammatory benefits of corticosteroids, including:

Various chronic or recurrent diseases of unknown etiology, such as ulcerative colitis and nephrosis

In acute adrenal insufficiency, prednisolone may be
effective because of its ability to correct the defect in carbohydrate
metabolism and relieve the impaired diuretic response to water,
characteristic of primary or secondary adrenal insufficiency. However,
because this agent lacks significant mineralocorticoid activity,
hydrocortisone sodium succinate, hydrocortisone, or cortisone should be used
when salt retention is indicated.

Dosage and Administration: The keystone of
satisfactory therapeutic management with prednisolone tablets, as with other
steroid predecessors, is individualization of dosage in reference to the
severity of the disease, the anticipated duration of steroid therapy, and
the animal patient's threshold or tolerance for steroid excess. The prime
objective of steroid therapy should be to achieve a satisfactory degree of
control with a minimum effective daily dose.

The dosage recommendations are suggested
average total daily doses and are intended as
guides. As with other orally administered corticosteroids, the total
daily dose of prednisolone should be given in equally divided doses. The
initial suppressive dose level is continued until a satisfactory clinical
response is obtained, a period usually of 2 to 7 days in the case of
musculoskeletal diseases, allergic conditions affecting the skin or
respiratory tract, and ocular inflammatory diseases. If a satisfactory
response is not obtained in 7 days, reevaluation of the case to confirm the
original diagnosis should be made. As soon as a satisfactory clinical
response is obtained, the daily dose should be reduced gradually, either to
termination of treatment in the case of acute conditions (e.g., seasonal
asthma, dermatitis, acute ocular inflammations) or to the minimal effective
maintenance dose level in the case of chronic conditions (e.g., rheumatoid
arthritis). In chronic conditions, and in rheumatoid arthritis especially,
it is important that the reduction in dosage from initial to maintenance
dose levels be accomplished slowly. The maintenance dose level should be
adjusted from time to time as required by fluctuation in the activity of the
disease and the animal's general status. Accumulated experience has shown
that the long-term benefits to be gained from continued steroid maintenance
are probably greater the lower the maintenance dose level. In rheumatoid
arthritis in particular, maintenance steroid therapy should be at the lowest
possible level.

Important: In the therapeutic management
of animal patients with chronic diseases such as rheumatoid arthritis,
prednisolone should be regarded as a highly valuable adjunct, to be used in
conjunction with, but not as a replacement for, standard therapeutic
measures.

DOSAGE: 2.5 mg per 10 lb (4.5 kg)
body weight per day. Average total daily oral doses for dogs are as follows:

5 to 20 lbs (2 to 9 kg): 1.25 to 5 mg

20 to 40 lbs 9 to 18 kg): 5 to 10 mg

40 to 80 lbs (18 to 36 kg): 10 to 20 mg

80 to 160 lbs (36 to 73kg): 20 to 40 mg

The total daily dose should be given in divided doses, 6 to
10 hours apart.

Efficacy Profile:

Short-Acting 12-36 hour duration

Permits low-level maintenance dose

Ideal for alternate day therapy

Safety Profile:

Prednisolone is one of the safest corticosteroids

Reduces the risk of adrenal suppression seen with potent, longer acting steroids such as dexamethasone, betamethasone or flumethasone

Federal law restricts this drug
to use by or on the order of a licensed veterinarian

Contraindications: Do not use in viral
infections. Prednisolone, like methylprednisolone, is contraindicated in
animals with peptic ulcer, corneal ulcer, and Cushingoid syndrome. The
presence of diabetes, osteoporosis, predisposition to thrombophlebitis,
hypertension, congestive heart failure, renal insufficiency, and active
tuberculosis necessitates carefully controlled use. Some of the above
conditions occur only rarely in dogs, but should be kept in mind.

Caution: Because of its inhibitory
effect on fibroplasia, prednisolone may mask the signs of infection and
enhance dissemination of the infecting organism. Hence, all animal patients
receiving prednisolone should be watched for evidence of intercurrent
infection. Should infection occur, it must be brought under control by use
of appropriate antibacterial measures, or administration of prednisolone
should be discontinued.

Warning: Not for human use. Clinical and
experimental data have demonstrated that corticosteroids administered orally
or by injection to animals may induce the first stage of parturition if used
during the last trimester of pregnancy and may precipitate premature
parturition followed by dystocia, fetal death, retained placenta, and
metritis.

Additionally, corticosteroids administered to dogs, rabbits,
and rodents during pregnancy have resulted in cleft palate in offspring.
Corticosteroids administered to dogs during pregnancy have also resulted in
other congenital anomalies, including deformed forelegs, phocomelia, and
anasarca.

Precautions: Prednisolone, like
methylprednisolone and other adrenocortical steroids, is a potent
therapeutic agent influencing the biochemical behavior of most, if not all,
tissues of the body. Because this anti-inflammatory steroid manifests little
sodium-retaining activity, the usual early sign of cortisone or
hydrocortisone overdosage (i.e., increase in body weight due to fluid
retention) is not a reliable index of overdosage. Hence, recommended dose
levels should not be exceeded, and all animal patients receiving
prednisolone should be under close medical supervision. All precautions
pertinent to the use of methylprednisolone apply to prednisolone. Moreover,
the veterinarian should endeavor to keep informed of current studies of
corticosteroids as they are reported in the veterinary literature.

Use of corticosteroids, depending on dose, duration and
specific steroid, may result in inhibition of endogenous steroid production
following drug withdrawal. In patients presently receiving or recently
withdrawn from systemic corticosteroid treatments, therapy with a
rapid-acting corticosteroid should be considered in unusually stressful
situations.

Adverse Reactions: Prednisolone is
similar to methylprednisolone in regard to kinds of side effects and
metabolic alterations to be anticipated when treatment is intensive or
prolonged. In animal patients with diabetes mellitus, use of prednisolone
may be associated with an increase in the insulin requirement. Negative
nitrogen balance may occur, particularly in animals that require protracted
maintenance therapy; measures to counteract persistent nitrogen loss include
a high protein intake and the administration, when indicated, of a suitable
anabolic agent. Excessive loss of potassium, like excessive retention of
sodium, is not likely to be induced by effective maintenance doses of
prednisolone. However, these effects should be kept in mind and the usual
regulatory measures employed as indicated. Ecchymotic manifestations in dogs
may occur. If such reactions do occur and are serious, reduction in dose or
discontinuance of prednisolone therapy may be indicated.

Side effects, such as SAP and SALT enzyme elevations, weight
loss, anorexia, polydipsia and polyuria have occurred following the use of
synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally
bloody) have also been observed. Cushing's syndrome in dogs has been
reported in association with prolonged or repeated steroid therapy.

Since prednisolone, like methylprednisolone, suppresses
endogenous adrenocortical activity, it is highly
important that the animal patient receiving prednisolone be under careful
observation, not only during the course of treatment, but for some time
after treatment is terminated. Adequate adrenocortical supportive therapy
with cortisone or hydrocortisone, and including ACTH, must be employed
promptly if the animal is subjected to any unusual stress such as surgery,
trauma, or severe infection.

How Supplied: PrednisTab is available as
5 mg compressed quarter-scored tablets in bottles of 1000 and 20 mg
compressed quarter-scored tablets in bottles of 500 and 1000. Caplet shape offers easy dosing. Scored tablets for accurate and convenient administration.

Store at controlled room
temperature 15°-30°C (59°-86°F).

LLoyd Laboratories

Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.